FDA Inspection
American Pharmaceutical Ingredients LLCAmerican Pharmaceutical Ingredients LLC – FDA Inspection, Dec 14, 2017
Record Details
This FDA Inspection record concerns American Pharmaceutical Ingredients LLC, with an inspection on December 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Emilie Kahn (Issuing Officer)
- Sarah E. Rhoades (FDA Associated Person)
View Company Profile
ID · 85c3385b-958d-4b18-86d8-a9411a578eb2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035379
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of American Pharmaceutical Ingredients LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for American Pharmaceutical Ingredients LLC
- FDA Inspection 1084863 - 2019-03-12
- FDA Inspection 913365 - 2015-02-10
- FDA Inspection 867080 - 2014-02-26
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.